By: Paul M. Karpecki, OD, FAAO Clinical Director – PECAA
One of the most common requests I receive from my fellow PECAA Members is to provide information on new technology. So we started the last month with one of the first published articles on Lumify, the eye whitener that doesn’t cause rebound hyperemia or tachyphylaxis.
So here we are almost midway through the year and there were actually a lot of new developments thus far, so let’s recap:
Not One, But Two New Glaucoma Medications!
It’s been over 20 years since we’ve had any fundamentally new topical drugs for glaucoma and 2018 essentially turns out two. I’m talking about Vyzulta (latanoprostene bunod 0.024%, Bausch Healthcare) and Rhopressa (netarsudil ophthalmic solution 0.02%, Aerie Pharmaceuticals). What is most exciting is that we finally have glaucoma medications that get at the crux of the disease – the trabecular meshwork!
Vyzulta, which is dosed QHS utilizes a PA but also butanediol mononitrate, that releases nitric oxide (NO). NO has been shown to relax the TM to increase outflow inducing cytoskeletal relaxation. In glaucoma patients the TM is often compacted, which thus prevents proper aqueous outflow. Studies have also shown that patients with glaucoma have a lower concentration of NO in their eyes due to high concentrations of NO synthase. My own experience shows Zyvulta to be a superior glaucoma medication in reducing IOP as a first line therapy and clinical studies showed it lowered IOP more than any previous glaucoma medication to date when compared to timolol BID.
Rhopressa is an entirely new class of glaucoma medication known as RhoKinase inhibitors. It is also a QHS drug and has unique properties making it a valuable medication in glaucoma management. It specifically targets the TM and can alter the cytosckeleton. It has demonstrated up to 5mmHg lowering, but what was interesting was that it was independent of the entering IOP. This means Rhopressa would easily make an ideal second medication but could be a good option as a primary treatment in normal tension glaucoma or early glaucoma in it’s ability to restructure the TM. So we have two drugs that finally target where we have the disease – the TM!
A Genetic Test Now Covered by Insurance
Other new developments include a CPT code (and coverage) for Avellino’s genetic testing for corneal dystrophies. This technology helps identify the various corneal dystrophies that can progress with UV exposure or refractive surgery. Differentiating these from EBMD or other dystrophies is critical if the patients is considering refractive surgery, but even just to prescribe blue blocking and UV protecting glasses to slow their progression.
They received a tier 1 Molecular Pathology code 813X0 to test for detection of the mutations for 5 distinct corneal dystrophies associated with mutations in the TGFBI gene (R124H, R124C, R124L, R555W, R555Q). This means identifying dystrophies like granular and lattice that need to be managed. In fact they are credentialed in most state sand by most payers. An exciting development is that they are working on new markers, such as those to identify keratoconus early, but now is the time to involve these technologies in your practice.
iLux for MGD
A major area of advance is that of managing meibomian gland dysfunction (MGD) and evaporative dry eye disease, which affects anywhere from 50-90 million Americans. One of the best technologies for MGD treatment to date is LipiFlow (and LipiView for imaging) and fortunately the cost of these technologies has come down over 65% from when I purchased them. Now a new product, iLux by Tearfilm Innovations, launched this past month. This new technology is quite impressive and the FDA data is compelling. It is an in-office expression technology for MGD and has an estimated cost of about $8500 (and disposables around $85). It uses light energy to warm the meibomian glands quickly and comfortably while the doctor views the expression through the magnifier at the top, The temperature readings are provided and you can customize the amount of pressure you apply necessary to achieve expression.
The FDA study for approval involved 142 patients in 8 different sites and looked at improvements in meibomian gland expression scores, tear film break-up time (TFBUT) and symptoms using an OSDI questionnaire. Meibomian gland scores showed an 18 point improvement in 4 weeks, which was substantially greater than the 5-point threshold for clinical significance. TFBUT improved
substantially at both week 2 and week 4 and the OSDI improved by an impressive 31 points! (The improvement necessary for clinical significance in symptoms using the OSDI was 7 points). A technology like the iLux clearly shows the need for eye care practitioners to begin incorporating in-office technologies to manage an overwhelming number of patients with MGD and evaporative dry eye.